1. Field of the Invention
This invention relates to the use of endogenous blood coagulants obtained from plasma protein in the form of a two-component fibrin sealant, said components being mixed at the instant they are delivered.
This invention also relates to a device for introducing the two-component fibrin sealant into a puncture channel in the vicinity of an arterial or venous puncture point.
2. Description of Prior Art
Many operations in human or veterinary medicine require puncturing of vessels. With percutaneous transluminar coronary angioplasty (PTCA), heart operations and catheterizations of the heart, in particular, it is necessary to close the punctured vessels again with great care. In most cases, this is performed by direct compression of up to one hour and a compression bandage which must be applied up to 24 hours and requires hospitalization of one to two days. Accordingly, there is the desire to find a means for a more rapid and secure closure of the puncture point.
A method by the name of Vasoseal was introduced during a meeting of the American Heart Association on 17 Nov. 1992 in New Orleans. In accordance with this method, two collagen plugs made of bovine collagen are pushed into the puncture channel as far as the puncture point. It was noted during the meeting that, besides the somewhat rare rejection reaction of the exogenous collagen, there are various other disadvantages or risks. It was also noted that this system is ineffective in many cases and that there is a certain danger of emboli. In approximately 46% of all cases, hematomas of an order of magnitude between 2 to 6 cm were formed. Weeks or months go by before the bovine collagen is completely resorbed. In addition, the method leads to increased scar formation which makes an ultrasonic examination more difficult. Finally, although hospitalization did not become superfluous, it was reduced by at least 24 hours. However, one of the most essential problems lies in the handling, that is, the introduction of the collagen plugs into the puncture channel. Because it is necessary to push two collagen plugs successively into the puncture channel, the user finds the penetration depth, for example, hard to determine. If the collagen plugs are pushed in too deeply, the collagen plug may be pushed through the puncture point into the vessel, resulting in an obstruction in the vessel or the vessel itself being pushed closed.